Overview

This trial is active, not recruiting.

Condition hiv infection
Treatments adherence reinforcement, antiretroviral therapy darunavir/r + raltegravir + 2 nrtis (as chosen by the investigators)
Phase phase 2
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Start date March 2013
End date May 2015
Trial size 201 participants
Trial identifier NCT02025868, ANRS 12269 THILAO

Summary

Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa.

HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA >1000 copies/ml) will be recruited and followed in two phases:

- First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers;

- Second, a 48-week phase, during which:

- Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement;

- Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART.

Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA <50 copies/ml at 64 weeks.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
adherence reinforcement
Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
antiretroviral therapy darunavir/r + raltegravir + 2 nrtis (as chosen by the investigators)
Second-line ART regimen : ongoing regimen at the time of inclusion will be continued. Third-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)

Primary Outcomes

Measure
Virologic efficacy of the adherence reinforcement intervention
time frame: Week 12
Persistent virologic efficacy of the adherence reinforcement intervention
time frame: Week 64
Virologic efficacy of 3rd-line ART
time frame: Week 64

Secondary Outcomes

Measure
Immunological efficacy of the adherence reinforcement intervention
time frame: Week 12
Immunological efficacy of 3rd-line ART
time frame: Week 64
Tolerance of 3rd-line ART drugs
time frame: Week 64
Adherence to 3rd-line ART
time frame: Week 64
Resistance to 1st and 2nd-line antiretroviral drugs
time frame: Week 12
Resistance to 1st, 2nd and 3rd-line antiretroviral drugs
time frame: Week 64
Plasma antiretroviral drugs concentration
time frame: Week 12
Plasma antiretroviral drugs concentration
time frame: Week 64

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age >18 years - Documented HIV-1 infection - History of failing a NNRTI-based 1st-line ART - Current PI-based 2nd-line ART >6 months - Plasma HIV-1 RNA >1000 copies/ml - Signed informed consent Exclusion Criteria: - HIV-2 infection - Any Severe clinical event under exploration - History of treatment including darunavir or raltegravir.

Additional Information

Official title Systematic "Adherence Intervention" Phase Before Switching to 3rd-line ART in Patients With 2nd-line ART Virologic Failure in Sub-Saharan Africa : a Phase 2b Non-randomized Study.
Principal investigator Serge P. Eholie, MD, MSc, Pr
Description Main objective To estimate, in sub-Saharan African HIV-1 infected adults who failed a NNRTI-base first-line ART and then a PI-based second-line ART: 1. The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase; 2. In patients who successfully resuppress at 12 weeks: The percentage of patients still with continuing succesfull virologic supression on 2nd-line ART at 64 weeks (and factors associated to success) ; 3. In patients with persistent failure at 12 weeks : The efficacy (and associated factors) at 64 weeks of a darunavir/r + raltegravir-based 3rd-line regimen. Number of participants : 200 Main outcome : - At 12 weeks : Proportion of patients with a plasma HIV-1 RNA <400 copies/ml and/or with a decrease in plasma HIV-1 RNA >2 log10 copies/ml between inclusion and 12 weeks; - At 64 weeks : proportion of patients with a plasma HIV-1 RNA <50 copies/ml. Inclusion criteria: - Age >18 years - Documented HIV-1 infection. - History of failing a NNRTI-based 1st-line ART - Current PI-based 2nd-line ART >6 months - Plasma HIV-1 RNA >1000 copies/ml - Signed informed consent
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).